- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02565706
Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption
25 października 2019 zaktualizowane przez: Jennifer Di Noia, William Paterson University of New Jersey
This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote farmers' market fruit and vegetable purchases and consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote fruit and vegetable (FV) consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
Designed to leverage vouchers provided to WIC participants for FV purchases through the Farmers' Market Nutrition Program (FMNP) and monthly cash value vouchers (CVVs) redeemable at farmers' markets, the lesson is conceptually grounded in formative research on knowledge, attitudes and skills influencing farmers' market FV purchases and consumption and theoretical understanding of approaches for modifying them.
Lesson content delivery is primarily through short video segments and audio output to increase accessibility for low-literate learners.
Informed by a community-based participatory research approach, WIC participants are engaged as full partners in the development of the lesson and the delivery of content (videos feature WIC participants).
The setting is a large WIC agency serving three New Jersey counties.
Separate samples of women were recruited to participate in 1) focus groups for guiding lesson content development (N = 56 participants) and pretesting the resulting content (N = 52 participants), 2) cognitive testing to assess the clarity and interpretability of items and response formats in measures of knowledge, attitudes and skills developed for the study (N = 15), 3) one-on-one sessions to assess reactions to initial versions of video segments developed for the lesson (N = 20), and 4) the outcome evaluation (N = 744).
Stratified based on FMNP voucher receipt, participants are randomized to receive the lesson or existing online health education.
Outcome measures (administered orally to reduce literacy demands of the response task) are completed at pretest (immediately before the lesson), posttest (two weeks after the lesson), and 3 and 6 months after posttesting.
Short- and long-term lesson effects on FV intake, FMNP voucher redemption and the redemption of CVVs at farmers' markets will be evaluated.
Evidence for mediation by knowledge, attitudes, and skills of lesson effects on FV intake and voucher redemption, dose-response relationships, and user satisfaction with the lesson also will be examined.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
744
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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New Jersey
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Paterson, New Jersey, Stany Zjednoczone, 07524
- Saint Joseph's WIC Program
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
Inclusion Criteria:
- Pregnant or postpartum WIC participant
- Female caregiver of infant/child WIC participant
Exclusion Criteria:
- Restrictions on food intake
- Classified by WIC as high risk/requiring an individualized nutrition care plan
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: WIC Fresh Start Program
Participants in this arm receive the Fresh Start program.
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The intervention is an online lesson to promote farmers' market FV purchases and consumption.
The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills.
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Aktywny komparator: Existing Online Health Education
Participants in this arm receive existing online WIC health education.
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Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron).
The lessons consist of an introductory segment presented with online text and graphics.
After reading this material, viewers have the option to complete one of four lesson activities.
The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson.
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Eksperymentalny: WIC Fresh Start Program (FMNP)
Participants in this arm receive the Fresh Start program and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.
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The intervention is an online lesson to promote farmers' market FV purchases and consumption.
The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills.
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Aktywny komparator: Existing Online Health Education (FMNP)
Participants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.
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Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron).
The lessons consist of an introductory segment presented with online text and graphics.
After reading this material, viewers have the option to complete one of four lesson activities.
The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Number of Participants Who Redeemed FMNP Vouchers
Ramy czasowe: 6 months (2015 farmers' market season [June to November 2015])
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The state WIC agency is providing data on FMNP voucher redemption.
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6 months (2015 farmers' market season [June to November 2015])
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Frequency of Fruit and Vegetable Intake
Ramy czasowe: Pretest, posttest (2 weeks after pretest), and 3- and 6-month follow-up
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Times per day fruits and vegetable are consumed as assessed by a validated food frequency questionnaire.
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Pretest, posttest (2 weeks after pretest), and 3- and 6-month follow-up
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Quantity of Fruit and Vegetable Intake
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Cups per day consumed of fruits and vegetables as assessed by a validated fruit and vegetable screener.
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Pretest, posttest, and 3- and 6-month follow-up
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets
Ramy czasowe: 6 months (2015 farmers' market season [June to November 2015])
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The state WIC agency is providing data on cash value voucher redemption.
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6 months (2015 farmers' market season [June to November 2015])
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Response to Survey Items Assessing Knowledge of the WIC Farmers' Market Nutrition Program Using a True/False Format.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Index of Knowledge of the FMNP Score range: 0-6 Higher scores indicates greater knowledge
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Pretest, posttest, and 3- and 6-month follow-up
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Response to an Item Assessing Knowledge of WIC-authorized Farmers' Markets Using a Yes/no Format.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Knowledge of a farmers' market with farmers approved by WIC to accept WIC farmers' Market Nutrition Program and Cash Value vouchers Scores: No (0) and yes (1).
Higher scores (yes responses) indicate that the respondent knows of a farmers' market with farmers approved by WIC to accept WIC farmers' Market Nutrition Program and Cash Value vouchers.
Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (knowledge of such markets) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Attitudes Towards Farmers' Market Fruits and Vegetables Using 7-point Likert Rating Scales.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Attitudes towards Farmers' Market Fruits and Vegetables Score range: 6-42 Higher scores indicate more favorable attitudes
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Awareness of Locally Grown, Seasonal Fruits and Vegetables Using a Yes/no Format.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Familiarity with Locally Grown Seasonal Items Score range: 0-3 Higher scores indicate greater familiarity
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Fruit and Vegetable Food Safety Skills Using 7-point Likert Rating Scales.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Fruit and Vegetable Food Safety Skills Score range: 19-85 Higher scores indicate greater skills
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Farmers' Market Asking Skills Using a Yes/no Format.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Farmers' Market Asking Skills Score range: 0-3 Higher scores indicate greater skills
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Positive Outcome Expectations for Consuming Locally Grown Fruits and Vegetables Using a Yes/no Format.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Positive Outcome Expectations for Consuming Locally Grown Fruit and Vegetables Score range:0-3 Higher scores indicate more favorable ratings
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Pretest, posttest, and 3- and 6-month follow-up
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Response to an Item Assessing Whether the Participant Ever Purchased Fruits and Vegetables at a Farmers' Market Using a Yes/no Format.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Lifetime Farmers' Market Fruit and Vegetable Purchases Scores: No (0), Yes (1).
Higher scores (yes responses) indicate indicate that the respondent has ever purchased fruits and vegetables at a farmers' market.
Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (having ever purchased fruits and vegetables at a farmers' market) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Farmers' Market Fruit and Vegetable Preparation Skills Using 7-point Likert Rating Scales.
Ramy czasowe: 2 weeks
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Farmers' Market Fruit and Vegetable Preparation Skills Score range:12-84 Higher scores indicate greater skills
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2 weeks
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Response to an Item Assessing Whether the Participant Purchased Fruits and Vegetables at a Farmers' Market in the Past Two Weeks Using a Yes/no Format.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Recent Farmers' Market Fruit and Vegetable Purchases Scores: No (0), Yes (1).
Higher scores (yes responses) indicate that the respondent purchased fruits and vegetables at a farmers' market in the past two weeks.
Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (having purchased fruits and vegetables at a farmers' market in the past two weeks) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.
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Pretest, posttest, and 3- and 6-month follow-up
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Response to an Item Assessing Behavioral Intentions to Purchase Fruits and Vegetables at a Farmers' Market in the Next Two Weeks Using a Yes/no Format.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Intentions to Purchase Fruits and Vegetables at a Farmers' Market Scores: no (0), Yes (1).
Higher scores (yes responses) indicate that the respondent intends to purchase fruits and vegetables at a farmers' market in the next two weeks.
Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (intending to purchase fruits and vegetables at a farmers' market in the next two weeks) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Knowledge of Locally Grown Seasonal Fruits and Vegetables Found at Farmers' Markets in July Using a Yes/no Format.
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Knowledge of Locally Grown Seasonal Fruits and Vegetables found at Farmers' Markets in July Score range:0-9 Higher scores indicate greater knowledge
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Food-specific Knowledge Using a True/False Format
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Food-specific Knowledge Score range: 2-13 Higher scores indicate greater knowledge
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Knowledge of Area Farmers' Markets
Ramy czasowe: Pretest, posttest, and 3- and 6-month follow-up
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Farmers' Market-specific Knowledge Score range:0-2 Higher scores indicate greater knowledge
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Pretest, posttest, and 3- and 6-month follow-up
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Jennifer Di Noia, PhD, Professor, Department of Sociology, William Paterson University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Di Noia J, Monica D, Sikorskii A, Cullen KW. Outcomes of a randomized controlled trial of nutrition education to promote farmers' market fruit and vegetable purchases and consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). BMC Nutr. 2017 Jun 21;3:48. doi: 10.1186/s40795-017-0172-0. eCollection 2017.
- Di Noia J, Monica D, Cullen KW, Perez-Escamilla R, Gray HL, Sikorskii A. Differences in Fruit and Vegetable Intake by Race/Ethnicity and by Hispanic Origin and Nativity Among Women in the Special Supplemental Nutrition Program for Women, Infants, and Children, 2015. Prev Chronic Dis. 2016 Aug 25;13:E115. doi: 10.5888/pcd13.160130.
- Di Noia J, Cullen KW, Monica D. Social Desirability Trait Is Associated with Self-Reported Vegetable Intake among Women Enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children. J Acad Nutr Diet. 2016 Dec;116(12):1942-1950. doi: 10.1016/j.jand.2016.07.008. Epub 2016 Sep 21.
- Di Noia J, Monica D, Cullen KW, Thompson D. Perceived Influences on Farmers' Market Use among Urban, WIC-enrolled Women. Am J Health Behav. 2017 Sep 1;41(5):618-629. doi: 10.5993/AJHB.41.5.11.
- Di Noia J, Monica D, Gray HL, Cullen KW. The Special Supplemental Nutrition Program for Women, Infants, and Children Fresh Start Randomized Controlled Trial: Baseline Participant Characteristics and Reliability of Measures. J Acad Nutr Diet. 2016 Dec;116(12):1899-1913. doi: 10.1016/j.jand.2016.07.020. Epub 2016 Sep 20.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 lipca 2014
Zakończenie podstawowe (Rzeczywisty)
1 czerwca 2016
Ukończenie studiów (Rzeczywisty)
1 czerwca 2016
Daty rejestracji na studia
Pierwszy przesłany
29 września 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
30 września 2015
Pierwszy wysłany (Oszacować)
1 października 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 października 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
25 października 2019
Ostatnia weryfikacja
1 października 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- WIC NEI-12-TX (Inny identyfikator: UC Davis)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAk
Opis planu IPD
The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request.
Ramy czasowe udostępniania IPD
Data are available for sharing.
Kryteria dostępu do udostępniania IPD
Contact the PI with requests (dinoiaj@wpunj.edu).
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na WIC Fresh Start Program
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California Polytechnic State University-San Luis...Women Infants and Children program WICZakończony
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University of MemphisUSANA Health SciencesRekrutacyjnyUtrata masy ciałaStany Zjednoczone
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University College DublinZakończonyZaburzenia ze spektrum autyzmuIrlandia
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University of New MexicoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)ZakończonyOtyłośćStany Zjednoczone
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University of ManitobaVictoria General Hospital FoundationNieznanyJakość życia | Otyłość | Ćwiczenie | Chirurgiczne leczenie otyłości | Obwodnica żołądka Roux-En-YKanada
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VA Office of Research and DevelopmentRekrutacyjnyGniew | Zespół stresu pourazowego | TBI | Weterani | Zapobieganie samobójstwom | TransdiagnostycznyStany Zjednoczone
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University of Alabama, TuscaloosaNieznanyŚCIEŻKA mocy | Start jak zwykleStany Zjednoczone